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To check is the test product is causing irritation or allergy in men/women after repeated applications of patch.

Human Repeat Insult Patch Test (HRIPT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027828
Enrollment
60
Registered
2020-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nicotine 7 mg transdermal patch: Single Nicotine patch will be applied on the test site for 24 hours. One time application Control Intervention1: 0.9% isotonic solution of saline: 0.04

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Smokers who smoke between 7 and 20 cigarettes/day. Having apparently healthy skin on test area. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: Pregnant women confirmed by UPT and lactating women. Users of non-nicotine drugs to stop smoking. Chronic illness which may influence the outcome of the study (Heart disease /diabetes/ serious liver or kidney problems/uncontrolled overactive thyroid gland or an adrenal gland tumour/stomach or duodenal ulcers or an inflamed oesophagus or gullet/ seizures or fits).

Design outcomes

Primary

MeasureTime frame
Evaluation of cutaneous tolerance by dermatological scoringTimepoint: Induction Phase: Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 15, Visit 17, Visit 19. Challenge Phase: Visit 22, Visit 23 and Visit 24—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Usha Chennuru

Cipla Ltd

Usha.Chennuru@Cipla.com02225761800

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026